510(k) · Cleared
ClearedCapno Probe a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optical Sensors, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Dec 21, 2000 as substantially equivalent to K951094 (Optical Sensors, Inc., 1996) and 2 other predicates after a 729-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Dec 21, 2000
- Review
- 729 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K951094 (1996). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK951094 Point-of-Care Arterial Blood Gas Monitoring SystemOptical Sensors, Inc. · 1996
- 1 generation backK963935 Olympus Critical Care Monitoring SystemOptical Sensors, Inc. · 1997
- This deviceK984579 Capno Probe aOptical Sensors, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK212425 MicroTrend SystemExostat Medical, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K212425MicroTrend SystemExostat Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951094 | Point-of-Care Arterial Blood Gas Monitoring System | Optical Sensors, Inc. | 1996 | — |
| −1 | K963935 | Olympus Critical Care Monitoring System | Optical Sensors, Inc. | 1997 | — |
| 0 (this device) | K984579 | Capno Probe a | Optical Sensors, Inc. | 2000 | — |
| +1 | K212425 | MicroTrend System | Exostat Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CCK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951094 | Point-of-Care Arterial Blood Gas Monitoring SystemSummary page 1…em Common Name: Carbon Dioxide Gas Analyzer Classification Name: CFR 868-1400 73CCK Carbon Dioxide Gas Analyzer Predicate Devices: SensiCath Blood Gas Sensor — 510(k) K 951094 OpticalCAM Blood Gas Measurement Systemn - 510(k) K963935 Datex-Engstrom Tonocap — 510(k) K 962638 1.0 Description of Device The… | 1996 |
| * | K963935 | Olympus Critical Care Monitoring SystemSummary page 1…Name: CFR 868-1400 73CCK Carbon Dioxide Gas Analyzer Predicate Devices: SensiCath Blood Gas Sensor — 510(k) K 951094 OpticalCAM Blood Gas Measurement Systemn - 510(k) K963935 Datex-Engstrom Tonocap — 510(k) K 962638 1.0 Description of Device The CapnoProbe A System provides a measurement of Sublingual… | 1997 |
| * | K962638 | Tonocap, TC-200 and Accessory CathetersSummary page 1…e Gas Analyzer Predicate Devices: SensiCath Blood Gas Sensor — 510(k) K 951094 OpticalCAM Blood Gas Measurement Systemn - 510(k) K963935 Datex-Engstrom Tonocap — 510(k) K 962638 1.0 Description of Device The CapnoProbe A System provides a measurement of Sublingual pCO, (SL CO;). The CapnoProbe A consists… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212425 | MicroTrend System | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K212425 (Exostat Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K951094.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
The CapnoProbe Sublingual Tonometer System is indicated for monitoring
sublingual PCO2. It is indicated for use in hospital patients. This device is
indicated for use by qualified medical personnel only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984579: Capno Probe a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984579
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026